Fluid collection devices, systems, and methods securing a protruding portion in position for use

ABSTRACT

Examples relate to systems, devices, and methods utilizing means for securing a protruding portion of a fluid permeable body disposed between a wearer&#39;s labia in position during use. The protruding portion is formed from fluid permeable material that allows urine or other fluids to pass therethrough. The fluid permeable body is disposed at least partially within a fluid impermeable barrier to prevent leakage of the fluid. The fluid is removed through a conduit disposed in a chamber within the fluid impermeable barrier.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 63/011,760 filed on Apr. 17, 2020, the disclosure of which isincorporated herein, in its entirety, by this reference.

BACKGROUND

An individual may have limited or impaired mobility such that typicalurination processes are challenging or impossible. For example, theindividual may have surgery or a disability that impairs mobility. Inanother example, the individual may have restricted travel conditionssuch as those experienced by pilots, drivers, and workers in hazardousareas. Additionally, fluid collection from the individual may be neededfor monitoring purposes or clinical testing.

Bed pans and urinary catheters, such as a Foley catheter, can be used toaddress some of these circumstances. However, bed pans and urinarycatheters have several problems associated therewith. For example, bedpans can be prone to discomfort, pressure ulcers spills, and otherhygiene issues. Urinary catheters be can be uncomfortable, painful, andcan cause urinary tract infections.

Thus, users and manufacturers of fluid collection devices continue toseek new and improved devices, systems, and methods to collect urine.

SUMMARY

Embodiments disclosed herein relate to fluid collection devices,systems, and methods utilizing means for securing a protruding portionof a fluid permeable body disposed between a wearer's labia in positionduring use. In an embodiment, a fluid collection device is disclosed.The fluid collection device includes a fluid impermeable barrier atleast partially defining a chamber and an opening. The fluid impermeablebarrier includes a first end region and a second end region. The fluidcollection device includes a fluid permeable body positioned at leastpartially within the chamber to extend across at least a portion of theopening and configured to allows fluid to move away from the opening.The fluid permeable body includes a protruding portion protruding out ofthe opening and that is sized and shaped to fit between labia of awearer. The fluid collection device includes a conduit disposed withinthe chamber for removing fluids therefrom.

In an embodiment, a fluid collection system is disclosed. The systemincludes the fluid collection device described above. The systemincludes a fluid storage container fluidly connected to the fluidcollection device via the conduit, the fluid storage container beingconfigured to store fluids therein. The system includes a vacuum sourcefluidly connected to the fluid storage container, the vacuum sourcebeing configured to provide vacuum force into the chamber via the fluidstorage container and the conduit.

In an embodiment, a method to collect fluid is disclosed. The methodincludes positioning the fluid collection device disclosed aboveadjacent to a urethra of a wearer effective to position the protrudingportion between the labia of the wearer. The method includes receivingfluid from the urethra into the fluid collection device. The methodincludes removing the fluid from the fluid collection device via theconduit.

Features from any of the disclosed embodiments may be used incombination with one another, without limitation. In addition, otherfeatures and advantages of the present disclosure will become apparentto those of ordinary skill in the art through consideration of thefollowing detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate several embodiments of the invention, whereinidentical reference numerals refer to identical or similar elements orfeatures in different views or embodiments shown in the drawings.

FIG. 1 is a schematic diagram of a fluid collection device, according toan embodiment.

FIG. 2 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 3 is a cross sectional view of the fluid collection device of FIG.2 taken along the plan A-A, according to an embodiment.

FIG. 4 is a cross-sectional view of a wearer having the fluid collectiondevice of FIGS. 2 and 3 positioned thereon during use, according to anembodiment.

FIG. 5 depicts the fluid collection device of FIGS. 2 and 3 positionedon the wearer for use, according to an embodiment.

FIG. 6 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 7 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 8 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 9 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 10 is an isometric view of the fluid collection device of FIG. 9being positioned on the wearer, according to an embodiment

FIG. 11 is an isometric view of a fluid collection device, according toan embodiment

FIG. 12 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 13 is an isometric view of the fluid collection device of FIG. 12positioned on a wearer, according to an embodiment.

FIG. 14 is side view of the fluid collection device of FIG. 12positioned on a wearer, according to an embodiment.

FIGS. 15 and 16 are isometric views of the fluid collection device ofFIG. 12 during and after positioning on a wearer, according toembodiments.

FIG. 17 is an isometric view of a fluid collection device viewed fromthe wearer-facing side, according to an embodiment.

FIG. 18 is an isometric view of the fluid collection device disposed ona wearer, according to an embodiment.

FIG. 19 is an isometric view of a fluid collection device, according toan embodiment.

FIG. 20 is an isometric view of the foldable body in different foldedconfigurations, according to an embodiment.

FIG. 21 is an isometric view of the fluid collection device of FIG. 19disposed on a wearer, according to an embodiment.

FIG. 22 is an isometric view of a fluid collection device, according toan embodiment.

FIGS. 23 and 24 are isometric views of the fluid collection device ofFIG. 22 disposed on a wearer, according to embodiments.

FIG. 25 is a block diagram of a system for collecting fluid, accordingto an embodiment

FIG. 26 is a flow diagram of a method for collecting fluid, according toan embodiment.

DETAILED DESCRIPTION

Embodiments disclosed herein include fluid collection devices andsystems utilizing portions sized and shaped to be inserted between labiafor securement and urine capture, as well as methods of using the fluidcollection devices and systems. The embodiments utilize means forsecuring a protruding portion of a fluid permeable body disposed betweena wearer's labia in position during use. Example fluid collectiondevices include a fluid impermeable barrier defining an interior chamberfor collecting fluids. The fluid collection devices include a fluidpermeable body at least partially disposed within the fluid impermeablebarrier and exposed through an opening therein. The fluid collectiondevices include a fluid permeable body having at least one permeable(e.g., porous) material for collecting and passing fluids therethrough,such as a wicking material (e.g., foam or spun plastic fibers). Thefluid permeable body includes a protruding portion sized and shaped toprotrude out of the opening of the fluid impermeable barrier. Theprotruding portion is sized and shaped to fit, and be retained, betweenthe labia of a female wearer. The fluid collection devices include ameans for retaining the protruding portion between the labia of thewearer. Accordingly, the devices, systems, and methods disclosed hereinprovide for positioning and retaining of the protruding portion of thefluid permeable body over the urethra within the labia of the wearer.

FIG. 1 is a block diagram of a fluid collection device 100, according toan embodiment. The fluid collection device 100 is sized, shaped, andcomposed to collect urine from the urethra of a wearer. The fluidcollection device 100 includes a fluid impermeable barrier 102 defininga chamber 104 therein, a fluid permeable body 115 disposed in thechamber 104 (e.g., interior chamber) and having a protruding portion 121protruding therefrom, a conduit 108 disposed in the chamber 104, and oneor more means 130 for retaining the protruding portion 121 between thelabia of the wearer. The protruding portion 121 of the fluid permeablebody 115 may be exposed to the external environment via an opening 106in the fluid impermeable barrier 102. During use, the fluid collectiondevice 100 may be positioned over the urethra of the wearer with theprotruding portion 121 disposed between the labia of the wearer.Accordingly, urine may be received in the protruding portion 121 andmoved into the chamber 104 via the opening 106. The urine may be removedfrom the fluid collection device 100 via the conduit 108 disposed withinthe chamber 104.

The fluid impermeable barrier 102 at least partially defines the chamber104 and opening 106. For example, the inner surface(s) 103 of the fluidimpermeable barrier 102 at least partially defines the chamber 104within the fluid collection device 100. The fluid impermeable barrier102 at least temporarily retains the fluid(s) in the chamber 104. Thefluid impermeable barrier 102 may be formed of any suitable fluidimpermeable material(s), such as a fluid impermeable polymer (e.g.,silicone, polypropylene, polyethylene, polyethylene terephthalate,thermoplastic elastomer(s), a polycarbonate, etc.), a metal film,natural rubber, another suitable material, or combinations thereof. Assuch, the fluid impermeable barrier 102 substantially prevents thefluid(s) from passing therethrough. In an example, the fluid impermeablebarrier 102 may be air permeable and liquid impermeable. In such anexample, the fluid impermeable barrier 102 may be formed of ahydrophobic material that defines a plurality of pores that are airpermeable but not liquid permeable. In an example, one or more portionsof at least an outer surface of the fluid impermeable barrier 102 may beformed from a soft and/or smooth material, thereby reducing chaffing.

In some examples, the fluid impermeable barrier 102 may be tubular(ignoring the opening), such as substantially cylindrical, oblong,prismatic, flattened tube, or any other extruded shape. The fluidimpermeable barrier 102 may be sized to fit between the legs of awearer. During use, an outer surface 105 of the fluid impermeablebarrier 102 may at least partially contact the wearer, such as thethighs of the wearer.

The opening 106 provides an ingress route for fluids to enter thechamber 104. The opening 106 may be defined by the fluid impermeablebarrier 102, such as by an inner edge of the fluid impermeable barrier102. For example, the opening 106 is formed in and extends through thefluid impermeable barrier 102, from the outer surface 105 to the innersurface 103, thereby enabling fluid(s) to enter the chamber 104 fromoutside of the fluid collection device 100. The opening 106 may belongitudinally extending along a longitudinal axis of the fluidcollection device 100. At least a portion of porous material(s) of thefluid permeable body 115 disposed in the chamber 104 may be exposedthrough the opening 106 to allow fluids to move inwardly into thechamber 104, such as via one or more of permeation, suction, gravity, orwicking. For example, the fluid permeable body 115 includes theprotruding portion 121 which extends through the opening 106. Theprotruding portion 121 receives fluid which is moved through the fluidpermeable body 115 into the chamber 104.

The protruding portion 121 of the fluid collection device 100 may bepositioned proximate to the urethra and urine may enter the chamber 104via the opening 106. When in use, the opening 106 may be elongated,longitudinally extending from a first location below the urethra to asecond location above the urethra (e.g., at or near the top of thevaginal opening or the pubic region). The opening 106 in the fluidimpermeable barrier 102 may exhibit a length that is measured along thelongitudinal axis of the fluid collection device 100 that may be atleast about 10% of the length of the fluid collection device 100, suchas about 25% to about 50%, about 40% to about 60%, about 50% to about75%, about 65% to about 85%, or about 75% to about 95% of the length ofthe fluid collection device 100.

The opening 106 in the fluid impermeable barrier 102 may exhibit a widththat is measured transverse to the longitudinal axis of the fluidcollection device 100 and may be at least about 10% of the circumferenceof the fluid collection device 100, such as about 25% to about 50%,about 40% to about 60%, about 50% to about 75%, about 65% to about 85%,or about 75% to about 100% of the circumference of the fluid collectiondevice 100. The opening 106 may exhibit a width that is greater than 50%of the circumference of the fluid collection device 100 because thevacuum (e.g., suction) through the conduit 108 pulls the fluid throughthe fluid permeable body 115 and into the conduit 108. The opening 106may be longitudinally oriented (e.g., having a major axis parallel tothe longitudinal axis of the device 100) or laterally oriented (e.g.,having a major axis perpendicular to the longitudinal axis of the device100).

The fluid collection device 100 includes the fluid permeable body 115disposed in the chamber 104. The fluid permeable body 115 may extendacross at least a portion (e.g., all) of the opening 106. At least aportion of the fluid permeable body 115 may be exposed to an environmentoutside of the chamber 104 through the opening 106. The fluid permeablebody 115 may wick any fluid away from the opening 106, therebypreventing the fluid from escaping the chamber 104.

The fluid permeable body 115 may include one or more of a fluidpermeable membrane 118 or a fluid permeable support 120. In someexamples, the fluid permeable support 120 and the fluid permeablemembrane 118 may be made of solely porous material(s), such as a wickingmaterial. At least a portion of the porous material of the fluidpermeable body 115 may be a wicking material configured to wick, draw,and/or allow transport any of the bodily fluids away from the opening106, thereby preventing bodily fluids from escaping the chamber 104. Theporous material may not include absorption of the bodily fluids into atleast a portion of the porous material. Put another way, substantiallyno absorption or solubility of the bodily fluids into the porousmaterial may take place after the porous material is exposed to thebodily fluids. While no absorption is desired, the term “substantiallyno absorption” may allow for nominal amounts of absorption and/orsolubility of the bodily fluids into the porous material (e.g.,absorbency), such as about 30 wt % of the dry weight of the porousmaterial, about 20%, about 10%, about 7 wt %, about 5 wt %, about 3 wt%, about 2 wt %, about 1 wt %, or about 0.5 wt % of the dry weight ofthe porous material. In some examples, the porous material may includeat least one absorbent or adsorbent material.

The fluid permeable membrane 118 may include any porous material or amaterial that may wick the fluid. For example, the fluid permeablemembrane 118 may include fabric, such as a gauze (e.g., a silk, linen,or cotton gauze), another soft fabric, or another smooth fabric. Thefluid permeable membrane 118 may include spun plastic fibers (e.g.,nylon), such as a spun plastic mat or bed. Forming the fluid permeablemembrane 118 from gauze, soft fabric, and/or smooth fabric may reducechaffing caused by alternative materials.

The fluid permeable membrane 118 is at least partially disposed in thechamber 104. The fluid permeable membrane 118 may extend across or outof at least a portion (e.g., all) of the opening 106. The fluidpermeable membrane 118 may wick fluid inwardly away from the opening106, thereby preventing fluid from escaping the chamber 104.

The fluid permeable body 115 of the fluid collection device 100 mayinclude the fluid permeable support 120 disposed in the chamber 104. Thefluid permeable support 120 is composed to support the fluid permeablemembrane 118 since the fluid permeable membrane 118 may be formed from afoldable, flimsy, or otherwise easily deformable material. For example,the fluid permeable support 120 may be positioned such that the fluidpermeable membrane 118 is disposed between the fluid permeable support120 and the fluid impermeable barrier 102. As such, the fluid permeablesupport 120 may support and maintain the position of the fluid permeablemembrane 118 thereon. The fluid permeable support 120 may include anymaterial that may wick the fluid, such as any of the fluid permeablemembrane materials disclosed herein. For example, the fluid permeablesupport 120 may be formed from any fluid porous material that is lessdeformable than the fluid permeable membrane 118, such as any of thematerials disclosed herein for the fluid permeable membrane 118, in amore dense or rigid form. In some examples, the fluid permeable support120 may include a porous polymer (e.g., nylon, polyester, polyurethane,polyethylene, polypropylene, etc.) structure, an open cell foam, or spunplastic fibers (e.g., spun nylon fibers). In some examples, the fluidpermeable membrane 118 may include gauze and the fluid permeable supportmay include spun nylon fibers. In some examples, the fluid permeablesupport 120 may be formed from fabric, felt, gauze, or combinationsthereof. In some examples, the fluid permeable support 120 may be formedfrom a natural material, such as cotton, wool, silk, or combinationsthereof. In such examples, the material may have a coating to prevent orlimit absorption of fluid into the material, such as a water repellentcoating. In some examples, the fluid permeable support 120 may beomitted from the fluid collection device 100. In some examples, thefluid permeable membrane 118 may be optional. For example, the fluidpermeable body 115 may include only the fluid permeable support 120.

The fluid permeable support 120 may have a greater permeability or agreater ability to wick fluids than the fluid permeable membrane 118,such as to move the fluid inwardly from the outer surface of the fluidcollection device 100. In some examples, the permeability or the wickingability of the fluid permeable support 120 and the fluid permeablemembrane 118 may be substantially the same.

The fluid permeable body 115 includes the protruding portion 121. Theprotruding portion 121 extends out of the chamber 104 through theopening 106. The protruding portion 121 may be a longitudinallyextending ridge, fin, mound, or the like that extends out of the opening106. The protruding portion 121 may include one or more of the fluidpermeable membrane 118 or the fluid permeable support 120. For example,the protruding portion 121 may include only the fluid permeable membrane118 such as a thicker portion of the fluid permeable membrane 118disposed in and extending from the opening 106. The protruding portion121 may have a substantially arcuate shape when viewed transverse to thelongitudinal axis of the fluid collection device.

The protruding portion 121 may extend longitudinally along at least aportion of the opening 106, such as along at least 20% of the length ofthe opening 106. For example, the protruding portion 121 may have alength that is at least about 1 cm, such as 1 cm to 15 cm, 2 cm to 5 cm,5 cm to 10 cm, 10 cm to 15 cm, or less than 20 cm. The protrudingportion 121 may have a width that is 50% or less than the length of theprotruding portion 121, such as 1% to 50%, 5% to 25%, or 25% to 50% ofthe length of the protruding portion 121. The height (above the fluidimpermeable barrier 102 at the opening 106) of the protruding portion121 may be at least 0.5 cm, such as 0.5 cm to 5 cm, 0.5 cm to 2 cm, 2 cmto 5 cm, or less than 5 cm.

The fluid permeable membrane 118 and the fluid permeable support 120 mayat least substantially completely fill the portions of the chamber 104that are not occupied by the conduit 108. In another example, the fluidpermeable membrane 118 and the fluid permeable support 120 may notsubstantially completely fill the portions of the chamber 104 that arenot occupied by the conduit 108. In such an example, the fluidcollection device 100 includes a reservoir 122 in the chamber 104.

The conduit 108 extends into the chamber 104. The conduit 108 may be atleast partially disposed in the chamber 104. The conduit 108 (e.g., adrainage tube) includes an inlet and outlet positioned downstream fromthe inlet. The conduit 108 may extend into the chamber 104 to any pointtherein. For example, the conduit 108 may be inserted into the chamber104 at a first end region 125 of the fluid collection device 100 andextend therethrough into the first end region 125 or to the second endregion 127. The conduit 108 may extend into the fluid impermeablebarrier 102 from the first end region 125 through to the reservoir 122such that the inlet of the conduit 108 is in fluid communication withthe reservoir 122. The fluid collected in the reservoir 122 may beremoved from the chamber 104 via the conduit 108.

In some examples, the conduit 108 may enter the chamber 104 in thesecond end region 127 and the inlet of the conduit 108 may be disposedin the second end region 127. The reservoir 122 may be disposed in thesecond end region 127 in any of the embodiments disclosed herein. Theinlet may be spaced from inner surface 103 of the fluid permeablesupport 120 in the first end region. In some examples, the inlet may bedisposed at the end of the fluid permeable support 120 in the first endregion 125, such as flush with the end of the fluid permeable support120. In some examples, the inlet may be disposed within the fluidpermeable support 120 such between the first end region 125 and thesecond end region 127.

The conduit 108 may include a flexible material such as plastic tubing(e.g., medical tubing). Such plastic tubing may include a thermoplasticelastomer, polyvinyl chloride, ethylene vinyl acetate,polytetrafluoroethylene, etc., tubing. In some examples, the conduit 108may include silicon or latex. In some examples, the conduit 108 mayinclude one or more portions that are resilient, such as to by havingone or more of a diameter or wall thickness that allows the conduit 108to be flexible. The conduit 108 may be at least partially transparent.In some examples, one or more portions of the conduit 108 may be frostedor opaque (e.g., black) to obscure visibility of the fluid(s) therein.

The fluid impermeable barrier 102, the fluid permeable membrane 118 andthe fluid permeable support 120 may be sized and shaped to have theconduit 108 at least partially disposed in the chamber 104. For example,at least one of the fluid permeable membrane 118 and the fluid permeablesupport 120 may be configured to form a space that accommodates theconduit 108. The fluid impermeable barrier 102 may define an aperturesized to receive the conduit 108. The conduit 108 may be disposed in thechamber 104 via the aperture. The aperture may be sized and shaped toform an at least substantially fluid tight seal against the conduit 108,thereby substantially preventing the fluid(s) from escaping the chamber104.

The fluid permeable body 115 may not substantially completely fill theportions of the chamber 104 that are not occupied by the conduit 108.The fluid collection device 100 may include the reservoir 122 therein.The reservoir 122 is a substantially unoccupied portion of the chamber104. The reservoir 122 may be defined between the fluid impermeablebarrier 102 and the fluid permeable body 115 (e.g., one or both of thefluid permeable membrane 118 and the fluid permeable support 120). Thefluid(s) emitted by the wearer may be drawn into the chamber 104 by thefluid permeable body 115 and may flow through the fluid permeablemembrane 118 and/or fluid permeable support 120 to the reservoir 122.The fluid impermeable barrier 102 may retain the fluid(s) in thereservoir 122. The reservoir 122 may be located in a portion of thefluid collection device expected to be positioned in a gravimetricallylow point of the fluid collection device when worn by a user. In suchexamples, the location of the inlet of the conduit 108 and the reservoir122 at the gravimetrically low point of the fluid collection deviceallows the fluids collected in the chamber 104 to drain into thereservoir 122 when the device is positioned on the wearer. Locating theinlet of the conduit 108 at or near a location expected to be thegravimetrically low point of the chamber 104 when worn by a user enablesthe conduit 108 to receive more of the fluid(s) than if inlet waslocated elsewhere and reduce the likelihood of pooling (e.g., pooling ofthe fluid(s) may cause microbe growth and foul odors). For instance, thefluid(s) in the fluid permeable body 115 may flow in any direction dueto capillary forces. However, the fluid(s) may exhibit a preference toflow in the direction of gravity, especially when at least a portion ofthe fluid permeable body 115 is saturated with the fluid(s).Accordingly, one or more of the inlet or the reservoir 122 may belocated in the first end region. While depicted in the first end region,the reservoir 122 may be located in any portion of the chamber 104 suchas the second end region 127 in a medial region between the first andsecond regions. In such examples, the conduit 108 may extend into thereservoir 122, such as through one or more of the fluid permeable body115 or fluid impermeable barrier 102 in the second end region 127 or themedial region.

Other embodiments of fluid impermeable barriers, fluid permeablemembranes, fluid permeable supports, cavities, conduits and their shapesand configurations are disclosed in U.S. patent application Ser. No.15/612,325 filed on Jun. 2, 2017; U.S. patent application Ser. No.15/260,103 filed on Sep. 8, 2016; and U.S. Pat. No. 10,226,376 filed onJun. 1, 2017, the disclosure of each of which is incorporated herein, inits entirety, by this reference.

The fluid collection device 100 includes one or more means 130 forretaining the protruding portion between the labia of the wearer. Theone or more means 130 for retaining the protruding portion between thelabia of the wearer may be integrated into the construction of one ormore of the fluid impermeable barrier 102 or the fluid permeable body115. The one or more means 130 for retaining the protruding portionbetween the labia of the wearer may be additional components, such asflaps, frames, straps, bands, adhesives, or the like attached to thefluid collection device 100. Various examples of the one or more means130 for retaining the protruding portion between the labia of the wearerare discussed in more detail below.

During use, the protruding portion 121 the fluid collection device 100may be positioned over the urethra and between the labia of the wearer.Urine may be collected in the fluid collection device 100 and removedfrom the wearer to the fluid storage container, such as via gravity orvacuum force. At least a portion of bodily waste (e.g., liquid orsemi-liquid stool) may be collected in the bodily waste collectionapparatus and removed to the at least one fluid storage container, suchas via gravity or vacuum force.

FIG. 2 is an isometric view of a fluid collection device 200, accordingto an embodiment. FIG. 3 is a cross sectional view of the fluidcollection device 200 of FIG. 2 taken along the plan A-A, according toan embodiment. The fluid collection device 200 may be similar oridentical to the fluid collection device 100, in one or more aspects.The fluid collection device 200 includes the fluid impermeable barrier102 having an opening 106 around an outer portion of a wearer-facingside thereof. The fluid impermeable barrier 102 defines the chamber 104therein. The fluid collection device 200 includes the fluid permeablebody 115 that transports urine from the wearer's urethra into thechamber 104 and eventually into the conduit 108, thereby preventing thedevice from retaining urine against the wearer's body. The fluidpermeable body 115 includes the protruding portion 121 which protrudesfrom chamber 104 via the opening 106. As shown, the protruding portion121 may be a longitudinally extending portion of the fluid permeablebody 115 that is sized and shaped to fit between the labia of thewearer. The protruding portion 121 may have any of the dimensions forthe protruding portion disclosed herein, such as length, width, height,or relationships therebetween. The protruding portion 121 extends out ofand away from the chamber 104 via the opening 106. The protrudingportion 121 may include one or both of the fluid permeable support 120or the fluid permeable membrane 118 (e.g., soft wicking material). Theprotruding portion 121 may be convex, such as having a first radius ofcurvature extending longitudinally along the longitudinal axis of thefluid collection device 100 and a second radius of curvature transverseto the first radius of curvature. The second radius of curvature may begreater than the first radius of curvature, such as at least 3 timeslarger, at least 10 times larger, or 3 times to 30 times larger than thesecond radius of curvature. The protruding portion 121 may have an apexof the first radius of curvature at a midpoint along the longitudinalaxis of the fluid collection device 100. The protruding portion 121 mayhave an apex of the first radius of curvature below a midpoint of thelongitudinal axis of the fluid collection device 100 (e.g., closer tothe first end region 125 than the second end region 127). The protrudingportion 121 may have an apex of the first radius of curvature above amidpoint of the longitudinal axis of the fluid collection device 100(e.g., closer to the second end region 127 than the first end region125).

The fluid collection device 100 may exhibit a boat shape with agenerally flat wearer-facing (e.g., front) surface. While not planar orperfectly flat, the front surface may be less than cylindrical, such asrounded in one or more portions thereof.

The fluid collection device 200 includes the means 230 for retaining theprotruding portion 121 between the labia of the wearer. The means 230for retaining the protruding portion 121 between the labia of the wearermay include geometry on at least a portion of the wearer-facing surfacethat is sized and shaped to accommodate the labia therein. For exampleand as shown in FIG. 3 , at least a portion of one or more of the fluidimpermeable barrier 102 and the fluid permeable body 115 may be shapedto accommodate the labia therein. For example, means 230 for retainingthe protruding portion 121 between the labia of the wearer may includevalleys 135 defined between the protruding portion 121 and a raised edge136. The valleys 135 may be longitudinally extending in parallel to theprotruding portion 121. The valleys 135 are sized and shaped to contourand fit over the labia. The valleys 135 may contain holes or material tocapture overflow and guide urine to the chamber for collection andtransport. In some examples, the valleys 135 are formed in the fluidpermeable body 115 which is exposed through the opening 106 defined atleast in part by the raised edge 136. In examples, the opening 106extends to the second end region 127 of the fluid collection device 200,but not to the first end region 125. In such examples, the end of thefluid collection device 200 in the second end region 127 may be open(e.g., the fluid permeable body 115 is exposed on the end) or may becapped by the fluid impermeable barrier 102. In some examples, thevalleys 135, raised edge 136, opening 106, and protruding portion 121may be disposed in the medial portion the fluid collection device 200.

The protruding portion 121 is sized and shaped to be placed between awearer's labia and contact urethral opening or tube to promote urinecapture by the fluid permeable body 115. FIG. 4 is a cross-sectionalview of a wearer 199 having the fluid collection device 200 of FIGS. 2and 3 positioned thereon during use. As shown, the protruding portion121 of the fluid collection device 200 may be positioned near theurethra 257 and the wearer's vagina 259. Accordingly, fluids from theurethra 257 and vagina 259 may be collected by the protruding portion121 and moved into the chamber of the fluid collection device 200. Asshown, the first end region 125 may be disposed nearer the rectum of thewearer and the second end region 127 may be disposed nearer the pubicregion of the wearer. Accordingly and as shown in FIG. 3 , the first endregion 125 may include the reservoir 122 and the inlet of the conduit108 therein. Of course, the reservoir 122 and inlet of the conduit 108may be disposed in the second end region 127 in one or more embodiments,such as when the position of the device is reversed. In such examples,the conduit 108 may enter the fluid collection device 200 in the firstend region 125 and extend through the fluid permeable body 115 (e.g.,fluid permeable support 120) to the second end region 127 where thereservoir 122 is disposed.

FIG. 5 depicts the fluid collection device 200 of FIGS. 2 and 3positioned on the wearer 199 for use, according to an embodiment. Thefluid collection device 200 can be secured via the labia only, such asvia inward pressure applied by the labia, fit or pressure on the labiasupplied by the means 230 for retaining the protruding portion 121between the labia of the wearer, or both. Accordingly, the fluidcollection device 200 may only be passively retained in place.

In some examples, other means (e.g., securement structures andapproaches) may be used to retain the protruding portion 121 between thelabia of the wearer, such as adhesive tabs, use of positioning in thegluteal cleft, straps around the waist and/or buttocks area. Forexample, adhesive flaps may be used to added to further secure to legs,pelvis, or buttocks. FIG. 6 is an isometric view of a fluid collectiondevice 300, according to an embodiment. The fluid collection device 300may include the fluid collection device 200 having one or more adhesiveflaps 247 thereon. The one or more adhesive flaps 247 provide means 330for retaining the protruding portion 121 between the labia of thewearer. Adhesive flaps 247 may be disposed on and extend from the fluidimpermeable barrier 102. Alternatively, the adhesive flaps 247 may besized and shaped to fit over the fluid collection device 200, such asextending from the buttocks to the pubic region of the wearer. Theadhesive on the adhesive flaps 247 may be disposed on the wearer-facingside (e.g., front) of the flaps or on the back of the flaps. Theadhesive may include a hydrogel or any other skin safe adhesive. Theadhesive flaps 247 may include any of the materials for the fluidimpermeable barrier 102, a fabric, a polymer, or the like. The adhesiveflaps 247 may be attached to the fluid impermeable barrier 102 via anadhesive, fasteners, integral formation with the fluid impermeablebarrier, welding, or the like.

Adhesive flaps 247 may extend longitudinally or laterally from (withrespect to the longitudinal axis) the fluid impermeable barrier. Theadhesive flaps 247 are sized and positioned on the fluid impermeablebarrier 102 to secure to the legs, pelvis, or buttocks of the wearer.For example, the adhesive flaps 247 may extend a distance to allow theadhesive thereon to bond to one or more of the wearer's hips, buttocks,pelvis, pubic region, or sacrum. Accordingly, the means 330 forretaining the protruding portion 121 between the labia of the wearerprovided by the adhesive flaps 247 retains the protruding portionbetween the labia of the wearer and in contact with the urethral openingof the wearer during use.

The means for retaining the protruding portion 121 between the labia ofthe wearer may include one or more straps sized and configured to wraparound one or more anatomical features of the wearer, such as one ormore waist or leg straps. FIG. 7 is an isometric view of a fluidcollection device 400, according to an embodiment. The fluid collectiondevice 400 may include the fluid collection device 200 having awaistband 248 thereon. Any of the fluid collection devices disclosedherein may be used. The waistband 248 may include waist straps extendingfrom the fluid permeable body. The waistband 248 provides the means 430for retaining the protruding portion 121 between the labia of thewearer.

The waistband 248 may include any of the materials for the fluidimpermeable barrier 102, a fabric, a polymer, or the like. The waistband248 may be attached to the fluid collection device 200 at the second endregion 127 thereof, such as via an adhesive, fastener(s), welding, orintegral formation with the fluid impermeable barrier. The waistband 248may have a length selected to extend an entire distance around awearer's waist or less than the circumference of the wearer's waist. Inthe former case, the waistband 248 may include attachments on the endsthereof to connect to secure the waistband around the waist of thewearer. In the latter case, the waistband 248 may include attachments onthe ends thereof to attach to the wearer (e.g., hips of the wearers) orthe wearer's clothes. As shown, the waste straps of the waistband 248extend from the second end region 127 of the fluid collection device 200to at least partially wrap around the waist of the wearer to retain theprotruding portion between the labia of the wearer.

FIG. 8 is an isometric view of a fluid collection device 500, accordingto an embodiment. The fluid collection device 500 includes the fluidcollection device 200 (or any other fluid collection device disclosedherein) and means 530 for retaining the protruding portion between thelabia of the wearer. The means 530 for retaining the protruding portion121 between the labia of the wearer includes one or more straps, such asthe waistband 248 and a strap 249. The means 530 may include theadditional strap 249 extending under the perineal region of the wearerfor better retention of the device. The straps may include fabric,gauze, adhesive, hook and loop fasteners, polymer material (e.g., thesame material as the fluid impermeable barrier 102), or othercomponents.

As shown in FIG. 8 , the straps may be formed into a garment, such as abelt or undergarment with an optional cloth portion 246 positioned tothe cover and retain the fluid collection device 200 therein when themeans 530 is used. For example, the one or more straps of the means 530include waistband 248 having the cloth portion 246 in a front regionthereof and the strap 249 extending from the cloth portion 246 to a backof the waistband 248 to form an undergarment. The cloth portion 248 maybe made of cloth, polymer, or the like.

In some examples, the cloth portion 246 may not be present. In suchexamples, the waistband 248 may be attached directly to the fluidcollection device 200 in the second end region 127 and the strap 249 maybe directly attached to the first end region 125 of the fluid collectiondevice 200 and the back of the waistband 248 to form an undergarmentincluding the fluid collection device 200 therein. In eitherconfiguration, the means 530 may at least partially wrap around thewaist of the wearer and the perineal region of the wearer to retain theprotruding portion of the fluid collection device in position on thewearer.

In some examples, the device may include an additional protrusion forsecuring the device in position. FIG. 9 is an isometric view of a fluidcollection device 900, according to an embodiment. The fluid collectiondevice 900 may be similar or identical to the fluid collection device200 in one or more aspects. For example, the fluid collection device 900includes a fluid impermeable barrier 902 which is similar or identicalto the fluid impermeable barrier 102 in one or more aspects. The fluidcollection device 900 includes a fluid permeable body 915 which issimilar or identical to the fluid permeable body 115 in one or moreaspects. The fluid permeable body 915 includes the protruding portion921, which is similar or identical to the protruding portion 121 in oneor more aspects. As shown, the fluid collection device 900 includes themeans 930 for retaining the protruding portion between the labia of thewearer. The means 930 includes an additional protrusion 945 forinserting between the wearer's buttocks to position and retain theprotruding portion 921 between the labia. For example, the additionalprotrusion 945 may be a longitudinally extending protrusion along thesame plane as the protruding portion 921. The additional protrusion 945may be formed in one or both of the fluid impermeable barrier 902 or thefluid permeable body 915. The additional protrusion 945 may extend fromthe first end region 125 of the fluid impermeable barrier 902 on awearer-facing side thereof. The additional protrusion 945 may extendfrom the first end region 125 toward the medial region of the fluidcollection device 900. The additional protrusion 945 may have any of thedimensions of the protruding portion 121 disclosed herein. Theadditional protrusion 945 may have a substantially arcuate shape whenviewed transverse to the longitudinal axis of the fluid collectiondevice 900.

The additional protrusion 945 is sized and shaped to fit between thebuttocks of the wearer to secure the device in position with theprotruding portion 921 being simultaneously positioned between thelabia. FIG. 10 is an isometric view of the fluid collection device 900of FIG. 9 being positioned on the wearer 199, according to anembodiment. The additional protrusion 945 may be inserted betweenbuttocks of the wearer 199. For example, as shown in FIG. 10 , the labiamay be spread open and the additional protrusion may be placed betweenthe buttocks. The fluid collection device 900 may then be pivoted aboutthe additional protrusion 945 until the protruding portion 921 ispositioned between the labia near the urethra. The conduit may becoupled to the fluid collection device 900 at the gravimetrically lowportion of the device, such as nearest the perineal region.

In some examples, the fluid collection device may be sized, shaped, andcomposed to comply to inward pressure (e.g., pinched) to be placed intoposition between the labia of the wearer. Such device may include meansfor retaining the protruding portion between the labia. FIG. 11 is anisometric view of a fluid collection device 1100, according to anembodiment. The fluid collection device 1100 includes to fluidimpermeable barrier 1102, the fluid permeable body 1115, and the conduit108. The fluid impermeable barrier 1102 may be similar or identical toany of the fluid impermeable barriers disclosed herein, in one or moreaspects. The fluid impermeable barrier 1102 may be shaped as a troughwith an at least partially open wearer-facing (e.g., front or upper)surface. For example, the opening 1106 is disposed at a wearer-facingside of the trough.

The fluid permeable body 1115 may be similar or identical to any of thefluid permeable bodies disclosed herein, in or more or aspects. Forexample, the fluid permeable body 1115 may include the fluid permeablesupport, the fluid permeable membrane, and protruding portion 1121. Thefluid permeable body 1115 is disposed at least partially within thechamber of the fluid impermeable barrier 1102. The protruding portion1121 may extend out of and above the opening 1106 (e.g., top of thetrough). The protruding portion 1121 may extend farther above theopening 1106 when the fluid collection device is pinched.

The protruding portion 1121 may be placed between the wearer's labiasuch as to contact the urethral tube or opening to promote urinecapture. The fluid permeable membrane (e.g., hydrophilic plastic mesh)may disposed over the top of the fluid permeable support in the troughto wick fluid into the fluid permeable support. The conduit 108 may bedisposed in the bottom of the trough to remove the collected urinetherefrom. The fluid permeable body 1115 (e.g., support and membrane)may alternatively be curved outward laterally or longitudinally toself-center on the vagina of the wearer. Other shapes may be utilized toprovide a contoured fit or provide greater engagement with the anatomyof the wearer.

The fluid impermeable barrier 1102 of the fluid collection device 1100may be semi-rigid with one or more resilient portions composed tomaintain their shape therein. For example, the fluid impermeable barrier1102 may include one or more spring members 1152 extending along thelongitudinal axis of the device, such as along the opening 1106 (e.g.,top of the trough). The spring members 1152 may include one or morematerials or bodies having a greater resiliency or rigidity than therest of the fluid impermeable barrier 1102. For example, the springmembers 1152 may include a polymer, a metal material, or the like havinga greater resiliency or rigidity than the fluid impermeable barrier 1102or material thereof. The spring members 1152 may be at least partiallydisposed in the fluid impermeable barrier 1102, such as having thematerial of the fluid impermeable barrier 1102 thereover. The springmembers 1152 may be spiraled bodies of resilient at least semi-rigidmaterial (e.g., lateral bending spring), a rod (e.g., torsion barspring), or the like, extending longitudinally along the opening 1106.The spring members 1152 are sized, shaped, and composed of material toprovide an outward bias on the opening 1106. Accordingly, when the fluidcollection device 1100 is pinched for the fluid permeable body 1115 tobe placed into position between the labia of the wearer, the springmembers 1152 provide an outward force keeping the trough open after theinward force is released (at which point the only inward force on thedevice is provided by the labia of the wearer). The spring members 1152then provide an outward force against the labia to maintain position ofthe protruding portion between the labia. Accordingly, the springmembers 1152 provide a means 1130 for retaining the protruding portionbetween the labia of the wearer.

To place the device, a user would pinch the spring member 1152 inwardand insert at least the protruding portion 1121 between wearer's labia.The user would release the device, allowing the spring member 1152 tospring back toward an original shape or size, leveraging the inside ofthe labia tissue to secure the fluid collection device 1100 in position.Accordingly, the fluid collection device 1100 would be secured via thelabia only. Alternatively or additionally, other securement approachesmay be utilized such as adhesive tabs, use positioning in the glutealcleft, straps around waist and/or buttocks area, or the like.

In some examples, the fluid collection devices may include elements topromote gripping by the user (e.g., wearer or health care professional),such as to aid the user to position the device on a wearer. Further, thefluid impermeable barrier may extends over a portion of the protrudingportion of the fluid permeable body. FIG. 12 is an isometric view of afluid collection device 1200, according to an embodiment. FIG. 13 is anisometric view of the fluid collection device 1200 of FIG. 12 positionedon a wearer. FIG. 14 is side view of the fluid collection device 1200 ofFIG. 12 positioned on a wearer. The fluid collection device 1200includes the fluid impermeable barrier 1202, the fluid permeable body1215, and the conduit 108.

The fluid permeable body 1215 may be similar or identical to any of thefluid permeable bodies disclosed herein, in or more or aspects. Forexample, the fluid permeable body 1215 may include a fluid permeablemembrane and a fluid permeable support as disclosed herein. The fluidpermeable body 1215 includes the protruding portion 1221, which extendsabove at least a portion of the substantially flat arcuate surface. Theprotruding portion 1221 may be sized and shaped to fit between the labiaof a wearer. For example, the protruding portion 1221 may be shaped as asubstantially hemi-cylindrical body extending longitudinally along thewearer-facing surface of the fluid permeable body 1215.

The fluid impermeable barrier 1202 may be similar or identical to any ofthe fluid impermeable barriers disclosed herein, in one or more aspects.The fluid impermeable barrier 1202 exhibit a wearer-facing side having agenerally flat arcuate shape sized and shaped to contour the anatomy ofa wearer's perineal and pubic regions. The fluid impermeable barrier1202 may include a covering portion 1229 that extends over some of theprotruding portion 1221, such as a lower portion thereof. The coveringportion 1229 may contour the protruding portion 1221 and extend abovethe flat arcuate shape of the fluid impermeable barrier 1202.Accordingly, the opening 1206 is defined at least in part by thecovering portion 1229 and the flat arcuate shape on the wearer-facingside of the fluid impermeable barrier 1202. The covering portion 1229 issized and shaped to fit between the labia of the wearer.

The covering portion 1229 may be disposed over a lower portion of thefluid impermeable barrier 1202, such as to form a sump, gutter, ortrough in the fluid impermeable barrier 1202. The covering portion 1229may be used to facilitate separation of the labia during placement aswell as provide a gutter to capture excess urine during use.Additionally, the covering portion 1229 may be sized and shaped toinsert into the gluteal cleft for positioning, securement, and retentionof the device during use. In such examples, the covering portion 1229may be positioned between the buttocks of the wearer and the protrudingportion 1221 may be positioned between the labia during use.

A back (e.g., opposite the wearer-facing side) of the fluid impermeablebarrier 1202 may include a narrow portion 1228 sized and shaped toprovide a grip section for gripping or pinching in a hand. The narrowportion 1228 may extend longitudinally along at least a portion of theback of the fluid impermeable barrier 1202.

The trough or sump formed from the covering portion 1229 and the chamberare sized and shaped to accommodate the fluid permeable body 1215therein. The fluid permeable body 1215 may protrude from the sump to fitbetween the labia of the wearer (e.g., engage the urethral opening). Thesump may be in fluid communication with the conduit via an aperture inthe fluid impermeable barrier, such as at a gravimetrically low pointtherein.

FIGS. 15 and 16 are isometric views of the fluid collection device 1200of FIG. 12 during and after positioning on a wearer. To position thefluid collection device 1200, a user 1237 would grip the narrow portion1228 and slide or wiggle the protruding portion 1221 on the oppositeside thereof between the labia. For example, the user 1237 may hold thenarrow portion 1228 and press the fluid collection device 1200 downwardto separate the labia (with the protruding portion 1221). The user 1237can release the handle when the device is positioned correctly. Thewearer 199 (e.g., user or patient) can return to a seated or laying downposition.

The fluid collection device 1200 may be secured via the labia only ormay include additional means for retaining the protruding portionbetween the labia such as adhesive tabs, straps around waist and/orbuttocks area, or any other means disclosed herein. FIG. 17 is anisometric view of a fluid collection device 1700 viewed from thewearer-facing side, according to an embodiment. FIG. 18 is an isometricview of the fluid collection device 1700 disposed on a wearer 199,according to an embodiment. As shown in FIGS. 17 and 18 , the fluidcollection device 1700 may include the fluid collection device 1200having adhesive flaps 1247 (e.g., wings) extending therefrom. Theadhesive flaps 1247 may be similar or identical to the adhesive flaps247 in one or more aspects. For example, the adhesive flaps 1247 may beattached and extend from the fluid impermeable barrier of the fluidcollection device 1200. The adhesive flaps 1247 includes an adhesivethereon to secure the fluid collection device 1700 to the wearer tomaintain the positioning of the protruding portion between the labia.Accordingly, the may adhere to the wearer to maintain the device in aselected position. As shown in FIG. 18 , the adhesive flaps 1247 mayadhere to the wearer 199 in the groin region. The adhesive flaps 1247may be sized, positioned, and located to attach to the wearer or thewearer's clothing in the pelvis, buttocks, legs, perineum, or regionsthereof. The adhesive flaps 1247 may be an additional means forretaining the protruding portion between the labia of the wearer on thefluid collection device 1200 to form the fluid collection device 1700.

Different styles of flaps, tabs, or means for retaining the protrudingportion between the labia of the wearer may be used on a fluidcollection device. In some examples, the fluid collection device mayinclude a foldable body sized, shaped, and composed to attach to thefluid impermeable barrier and the wearer to bias the protruding portiontoward the wearer during use. FIG. 19 is an isometric view of a fluidcollection device 1900, according to an embodiment. The fluid collectiondevice 1900 may be similar or identical to any of the fluid collectiondevices disclosed herein, in one or more aspects. For example, the fluidcollection device 1900 includes the fluid impermeable barrier 1902, thefluid permeable body 1915, the conduit 108, and the means 1930 forretaining the protruding portion between the labia of the wearer. Themeans 1930 for retaining the protruding portion between the labia of thewearer includes the foldable body 1960. The foldable body 1960 may beattached to the fluid impermeable barrier 1902 and provide a bias (e.g.,force) the protruding portion toward the wearer during use.

The fluid impermeable barrier 1902 may be similar or identical to any ofthe fluid impermeable barriers disclosed herein, on one or more aspectssuch as materials, shape, or the like. For example, the fluidimpermeable barrier 1902 defines a chamber therein, which is incommunication with the environment outside of the chamber via an openingin the fluid impermeable barrier 1902. As shown, the fluid impermeablebarrier may be substantially cylindrical with the opening extendinglongitudinally along a longitudinal axis thereof. As shown in FIG. 19 ,the fluid impermeable barrier 1902 may be tube shaped with a firstclosed end and a second end having an aperture therein for accommodatingthe conduit 108 therein. The aperture may extend axially away from thelongitudinal axis of the fluid collection device 1900 (to keep theconduit 108 from becoming tangled under or over the wearer during use)or may extend along the longitudinal axis of thereof.

The fluid permeable body 1915 may be similar to any of the fluidpermeable bodies disclosed herein in one or more aspects. For example,the fluid permeable body 1915 may include one or more of the fluidpermeable membrane, the fluid permeable support, or the protrudingportion 1921. The fluid permeable membrane, the fluid permeable support,and the protruding portion 1921, may be similar or identical to fluidany of permeable membranes, the fluid permeable supports, or theprotruding portions disclosed herein, in one or more aspects. Forexample, the protruding portion 1921 is sized and shaped to extend outof and away from the opening of the fluid impermeable barrier 1902 tofit between the labia of the wearer during use. Accordingly, theprotruding portion 1921 may be placed between the wearer's labia, suchas to contact the urethral opening to promote urine capture. Theprotruding portion 1921 may receive urine from the urethra of the wearerand the material of the fluid permeable body 115 may facilitatetransport of the fluid into the chamber therein for removal therefromvia the conduit 108.

The foldable body 1960 includes a body formed from a foldable materialsuch as a polymer, paper, fabric, or the like. The foldable body 1960may be at least semi-rigid, such that the non-folded portions of thefoldable body 1960 retain at least some rigidity when folded. Thefoldable body 1960 includes an adhesive 1967 or other attachment meansfor attaching to the wearer or the wearers clothing. For example, thefoldable body 1960 includes adhesive 1967 at the lateral ends thereof.The foldable body 1960 is sized and dimensioned to position the adhesive1967 at a selected point on the anatomy of the wearer, such as on theinner thighs or groin of the wearer.

FIG. 20 is an isometric view of the foldable body 1960 in differentfolded configurations, according to an embodiment. The foldable body1960 includes a first fold 1961 along a portion (e.g., center) thereof,a cutout portion 1964 defined between cuts 1963 perpendicular to thefirst fold 1961, and a second fold 1962 in the in the cutout portion1964, the second fold 1962 being oriented to fold in a directionopposite to the first fold 1961. The cutout portion 1964 is partiallyseparated from the main portion of the foldable body 1960 by the cuts1963. When opened, the foldable body 1960 is substantially flat. Thefirst and second folds may be substantially collinear when the foldablebody 1960 is flat. When bent, the cutout portion 1964 and the secondfold 1962 bends away from the first fold 1961. When the first fold 1961is folded, the second fold 1962 folds in the opposite direction and whenthe first fold 1961 is unfolded (e.g., body is flattened), the secondfold 1962 unfolds (e.g., flattens).

FIG. 21 is an isometric view of the fluid collection device 1900 of FIG.19 disposed on a wearer 199, according to an embodiment. When the wearer199 closes their legs, the first fold 1961 bends away from the wearer199 causing the second fold 1962 to bend toward the labia region.Accordingly, the fluid collection device 1900 attached thereto ispressed against the wearer to ensure securement of the protrudingportion between the labia.

The foldable body 1960 may be attached to the fluid collection device1900 via an adhesive, fasteners, integral formation, or fitting within aportion of the fluid impermeable barrier 1902. In some examples, atleast a portion of the fluid impermeable barrier 1902 may be disposedbetween the first fold 1961 and the second fold 1962. In such examples,the fluid impermeable barrier 1902 may include one or more flanges,cuts, tabs, slots, or other features for retaining a portion thefoldable body 1960 thereon or therebeneath. As shown in FIG. 21 , thefluid impermeable barrier 1902 may include a flange 1929 longitudinallyextending along a back side (e.g., opposite the wearer-facing side andopening) thereof. The flange 1929 may be set-off from at least a portionof the fluid impermeable barrier 1902 to accommodate at least a portionof the foldable body 1960 therebetween. At least a portion of the fluidimpermeable barrier 1902 may be disposed between the first fold 1961 andthe second fold 1962. Accordingly, the flange 1929 and the foldable body1960 may make up the means 1930 for retaining the protruding portionbetween the labia of the wearer. For example, the second fold 1962 ofthe foldable body 1960 may be disposed beneath the flange 1929 to retainthe foldable body 1960 on the fluid impermeable barrier 1902. In someexamples, the fluid collection device 1900 may be retained between thelabia by any of the other means disclosed herein.

FIG. 22 is an isometric view of a fluid collection device 2200,according to an embodiment. FIGS. 23 and 24 are isometric views of thefluid collection device 2200 of FIG. 22 disposed on a wearer, accordingto embodiments. The fluid collection device 2200 may be similar oridentical to any of the fluid collection devices disclosed herein, in ormore aspects. For example, the fluid collection device 2200 includes thefluid impermeable barrier 2202, the fluid permeable body 2215, theconduit 108.

The fluid impermeable barrier 2202 may be similar or identical to any ofthe fluid impermeable barriers disclosed herein, on one or more aspectssuch as materials, shape, or the like. For example, the fluidimpermeable barrier 2202 defines a chamber 2204 therein, which is incommunication with the environment outside of the chamber 2204 via anopening 2206 in the fluid impermeable barrier 2202. The fluidimpermeable barrier may be sized and shaped to align with and fit overat least a portion of the labia of the wearer. For example and as shown,the fluid impermeable barrier 2202 may be substantially dome shaped(e.g., convex) with the opening 2206 defined at, and extending around,the lateral base edges thereof (e.g., the mouth of the dome on awearer-facing side thereof). The outer base defining the opening may beshaped to contour to the anatomy of the vaginal region. The domed shapemay be elongated to exhibit a longitudinal axis, a first end region, anda second end region. One or more portions of the fluid impermeablebarrier 2202 may be at least semi-rigid to prevent collapse during use.

In some examples, the base of the dome may be at least partially arcuatesuch as to contour the anatomy of the wearer in the perineal to pubicregion along the sagittal plane. As shown in FIG. 24 , the base of thedome may be sized and shaped to allow the opening to apply inwardpressure (e.g., pinching pressure) from the ends of the arcuate base.Such dimensions may be a means for retaining the protruding portionbetween the labia of the wearer. In some examples, the fluid impermeablebarrier 2202 may exhibit a thicker construction or additional memberaround the base of the dome, such as to retain shape during use. In someexamples, the fluid impermeable barrier 2202 may exhibit a texturedsurface around the base of the dome, such as to provide a selectedamount of grip or tension on the skin of the wearer. The texturing mayinclude a pattern providing a selected amount of surface contact,suction cups, or any other pattern for providing a selected amount ofengagement with skin of a wearer. Such texturing may be a means forretaining the protruding portion between the labia of the wearer. Thefluid collection device 2200 may be secured to a wearer via an adhesivering around the fluid impermeable barrier 2202 (e.g., base of dome).Such adhesive may be a means for retaining the protruding portionbetween the labia of the wearer.

The fluid impermeable barrier 2202 may have a narrow portion 2228 on anouter surface thereof sized and shaped to provide a grip section forgripping or pinching in a hand (e.g., to form a handle). The narrowportion 2228 may protrude from the fluid impermeable barrier 2202. Thefluid impermeable barrier 2202 may include one or more transparentportions 2229 for viewing the interior of the device and retrainingexcess urine therein during use, such as a polymer film. The fluidimpermeable barrier 2202 includes an aperture for receiving the conduit108 in a region thereof expected to be at or near a gravimetrically lowpoint of the fluid collection device during use. For example, theaperture may be located on the first end region of the fluid collectiondevice 2200. The aperture may be in direct communication with the fluidpermeable body 2215, such as to allow fluids collected in the fluidpermeable body 2215 to be transported to the conduit 108. Such aconfiguration may prevent fluids from pooling within the dome. Theconduit 108 may be in fluid communication with an end of the fluidpermeable body 2215. Accordingly, the fluid permeable body 2215transports urine from wearer's body to the conduit 108, preventing thedevice from retaining urine.

The fluid permeable body 2215 may be similar to any of the fluidpermeable bodies disclosed herein in one or more aspects. For example,the fluid permeable body 2215 may include one or more of the fluidpermeable membrane, the fluid permeable support, or the protrudingportion 2221. The fluid permeable membrane may be disposed over at leasta portion of the fluid permeable support. The fluid permeable membraneor the fluid permeable support may be similar or identical to fluid anyof permeable membranes or the fluid permeable supports disclosed herein,in one or more aspects. The fluid permeable body 2215 may be columnar,such as substantially cylindrical, and curved to bend outwardly from theopening 2206. Accordingly, the outward bend of the fluid permeable body2215 provides the protruding portion 2221. The protruding portion 2221may be at the apex or apex region of the fluid permeable body 2215. Atleast the portion of the fluid impermeable barrier 2202 forming theprotruding portion 2221 is sized and shaped to fit between the labia ofthe wearer during use. Accordingly, the protruding portion 2221 may beplaced between the wearer's labia, such as to contact the urethralopening to promote urine capture. The protruding portion 2221 mayreceive urine from the urethra of the wearer and the material of thefluid permeable body 2215 may facilitate transport of the fluid into theconduit 108.

The fluid permeable body 2215 may not be in contact with one or moreportions of the interior surface of the fluid impermeable barrier 2202.For example, the fluid permeable body 2215 may be attached to and spanacross the chamber of the domed fluid impermeable barrier 2202, from onepoint therein to another point therein. For example, the fluid permeablebody 2215 may be attached to the fluid impermeable barrier 2202 near theopening 2206 at the first end region and the second end region to spanacross the interior region of the chamber 2204. Accordingly, the fluidpermeable body 2215 may only contact the fluid impermeable barrier atselected points therein (e.g., in the first and second end regions).

To promote vacuum draw from the wearer and discourage drawing of air,the side of the fluid permeable body 2215 that faces away from thewearer may be covered with a fluid impermeable material, such as apolymer film.

Any of the means for retaining the protruding portion between the labiaof the wearer of any of the fluid collection devices disclosed hereinmay be used with any of the other fluid collection devices disclosedherein, such as in additional to or alternatively to the fluidcollection devices described therewith.

Any of the fluid collection devices disclosed herein may be used insystems for collecting fluids. FIG. 25 is a block diagram of a system2500 for collecting fluid, according to an embodiment. The system 2500includes a fluid collection device 2501, a fluid storage container 2519,and a vacuum source 2529. The fluid collection device 2501, the fluidstorage container 2519, and the vacuum source 2529 may be fluidlycoupled to each other via one or more conduits 108. For example, fluidcollection device 2501 may be operably coupled (e.g., fluidly connected)to one or more of the fluid storage container 2519 or the vacuum source2529 via the conduits 108.

The fluid collection device 2501 may be similar or identical to any ofthe fluid collection devices disclosed herein. For example, the fluidcollection device 2501 may include a fluid impermeable barrier and afluid permeable body having a protruding portion extending from anopening in the fluid impermeable barrier, as disclosed herein. The fluidcollection device may include any of the protruding portions and anycombination of the means for retaining the protruding portion betweenthe labia of the wearer disclosed herein. The fluid collection device2501 may include the conduit 108 including an inlet and an outlet asdisclosed herein. The outlet may be fluidly coupled to the fluid storagecontainer 2519 and the inlet may be positioned in the fluid collectiondevice 2501 such as in a portion of the chamber therein selected to beat a gravimetrically low point of the fluid collection device 2501 whenworn by a user (e.g., reservoir).

The conduit 108 is coupled to and at least partially extends between oneor more of the fluid storage container 2519 and the vacuum source 2529.Accordingly, the vacuum source 2529 may be fluidly connected to thefluid storage container 2519 via the conduit 108. In an example, theconduit 108 is directly connected to the vacuum source 2529. In someexamples, the conduit 108 may be indirectly connected to at least one ofthe fluid storage container 2519 and the vacuum source 2529. In someexamples, the conduit 108 may be secured to a wearer's skin with acatheter securement device, such as a STATLOCK® catheter securementdevice available from C. R. Bard, Inc., including but not limited tothose disclosed in U.S. Pat. Nos. 6,117,163; 6,123,398; and 8,211,063,the disclosures of which are all incorporated herein by reference intheir entirety.

Fluid (e.g., urine or other bodily fluids) collected in the fluidcollection device 2501 may be removed from the fluid collection device2501 via the conduit 108. Vacuum or suction force may be applied toremove fluid from the fluid collection device via the conduit eitherdirectly or indirectly. The vacuum force may be applied indirectly viathe fluid storage container 2519. For example, the second open end ofthe conduit 108 may be disposed within the fluid storage container 2519and an additional conduit 108 may extend from the fluid storagecontainer 2519 to the vacuum source 2529. Accordingly, the vacuum source2529 may indirectly apply vacuum or suction force into the fluidcollection device 2501 (e.g., chamber therein) via the fluid storagecontainer 2519 and conduit 108. As the fluid is drained from the chamberof the fluid collection device 2501, the fluid may travel through thefirst section of conduit 108 to the fluid storage container 2519 whereit may be retained. The fluid storage container 2519 is constructed tostore fluids therein. The fluid storage container 2519 may be asubstantially rigid container, such as a jar, a canister, or the like.The fluid storage container may include a bag in some examples.

The vacuum source 2529 may include one or more of a vacuum pump, awall-mounted vacuum line, or a hand pump. For example, the vacuum source2529 may include one or more of a manual vacuum pump, and electricvacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump,a magnetically driven pump, a peristaltic pump, or any pump configuredto produce a vacuum. In examples, the vacuum source 2529 may be aportable vacuum source powered by one or more of a power cord (e.g.,connected to a power socket), one or more batteries, or even manualpower (e.g., a hand operated vacuum pump).

FIG. 26 is a flow diagram of a method 2600 for collecting fluid,according to an embodiment. The method 2600 includes a block 2610 ofpositioning any of the fluid collection devices disclosed hereinadjacent to a urethra of a wearer effective to position the protrudingportion between the labia of the wearer; a block 2620 of engaging themeans for retaining the protruding portion between the labia of thewearer; a block 2630 of receiving fluid from the urethra into the fluidcollection device; and a block 2640 of removing the fluid from the fluidcollection device via the conduit. Any the blocks 2610, 2620, 2630, and2640 of the method 2600 may be performed in different orders, split intomultiple acts, modified, supplemented, or combined. For example, theblocks 2610 and 2620 may be combined into a single block. In someexamples, one or more of the blocks 2610-2640 of the method 2600 may beomitted.

Block 2610 of positioning any of the fluid collection devices disclosedherein adjacent to a urethra of a wearer effective to position theprotruding portion between the labia of the wearer may include utilizingany of the fluid collection devices disclosed herein. Positioning any ofthe fluid collection devices disclosed herein adjacent to a urethra mayinclude positioning the protruding portion between the labia of thewearer. Positioning any of the fluid collection devices disclosed hereinadjacent to a urethra may include positioning the protruding portion incontact with or adjacent to the urethral opening of the wearer.

Block 2620 of engaging the means for retaining the protruding portionbetween the labia of the wearer includes engaging any of the means forretaining the protruding portion between the labia of the wearerdisclosed herein in contact with the wearer or wearer's clothing. Inexamples, engaging the means for retaining may include adhering orsecuring the means to the wearer or the wearer's clothing.

In some examples, the means for retaining the protruding portion betweenthe labia of the wearer may include adhesive flaps disposed on the fluidimpermeable barrier, and engaging the means for retaining the protrudingportion between the labia of the wearer includes adhering the adhesiveflaps to the wearer or clothing of the wearer.

In some examples, the means for retaining the protruding portion betweenthe labia of the wearer may include one or more strap sized andconfigured to wrap around one or more anatomical features of the wearer,and engaging the means for retaining the protruding portion between thelabia of the wearer includes wrapping the one or more straps around atleast one of the legs, pelvis, or buttocks of the wearer.

In some examples, the means for retaining the protruding portion betweenthe labia of the wearer may include an additional protrusion extendingfrom the first end region of the fluid impermeable barrier on awearer-facing side thereof, and engaging the means for retaining theprotruding portion between the labia of the wearer includes positioningthe additional protrusion between the buttocks of the wearer.

In some examples, the fluid impermeable barrier may be shaped as atrough and the opening is disposed at a wearer-facing side of thetrough. In such examples, the means for retaining the protruding portionbetween the labia of the wearer may include a plurality of springmembers extending longitudinally along the opening, the plurality ofspring members being configured to provide an outward bias on theopening. In such examples, engaging the means for retaining theprotruding portion between the labia of the wearer may include pinchingthe fluid impermeable barrier to bias the plurality of spring membersinward, placing the protruding portion between the labia of the wearer,and releasing the plurality of spring members. The spring members willallow the fluid impermeable barrier to at least partially retain itsshape and provide some engagement between the labia and the fluidimpermeable barrier and the fluid permeable body.

In some examples, the means for retaining the protruding portion betweenthe labia of the wearer may include a foldable body configured to attachto the fluid impermeable barrier and the wearer and to bias theprotruding portion toward the wearer. In such examples, engaging themeans for retaining the protruding portion between the labia of thewearer includes attaching lateral ends of the foldable body to the innerthighs of the wearer, such as via an adhesive thereon.

In some examples, the fluid impermeable barrier may include asubstantially domed shape and sized to at least partially fit over thelabia of the wearer and the opening is defined at a base edge of thedomed shape, the fluid permeable body is attached to the chamber of thefluid impermeable barrier at the first end region and the second endregion, and the fluid permeable body is substantially cylindrical andcurved to bend outwardly from the opening. In such examples, positioningany of the fluid collection devices disclosed herein adjacent to aurethra of a wearer effective to position the protruding portion betweenthe labia of the wearer includes positioning the curved fluid permeablebody between the labia of the wearer. The means for retaining theprotruding portion between the labia of the wearer may include theopening of the fluid impermeable barrier. In such examples, engaging themeans for retaining the protruding portion between the labia of thewearer may include contacting the opening of the fluid permeable body tothe wearer, such as around at least a portion of the labia of thewearer, effective to adhere or provide frictional engagement with thewearer.

In some examples, the means for retaining the protruding portion betweenthe labia of the wearer may include valleys disposed on the wearerfacing surface of the fluid collection device. In such examples,engaging the means for retaining the protruding portion between thelabia of the wearer may include disposing the valleys in the wearerfacing surface of the fluid collection device over the labia of thewearer, such as to at least partially contain the labia therein.

Engaging the means for retaining the protruding portion between thelabia of the wearer may include engaging any combination of meansdisclosed herein with the wearer or the wearer's clothing.

Block 2630 of receiving fluid from the urethra into the fluid collectiondevice may include receiving the fluid into fluid permeable body, suchas via the protruding portion. Receiving fluid from the urethra into thefluid collection device may include wicking the fluid into the chamberof the fluid collection device via the fluid permeably body (e.g., fluidpermeable membrane and fluid permeable support). Receiving fluid fromthe urethra into the fluid collection device may include may includeflowing the fluid towards a portion of the chamber of the fluidcollection device that is fluidly coupled to one or more of agravimetrically low portion of the fluid chamber, an inlet of a conduit,or a reservoir.

Block 2640 of removing the fluid from the fluid collection device viathe conduit may include removing at least some of the fluid from thechamber of the fluid collection device. Removing the fluid from thefluid collection device via the conduit may include removing at leastsome of the fluid from the fluid permeable body of the fluid collectiondevice. Removing the fluid from the fluid collection device via theconduit may include applying vacuum in the chamber, such as via any ofthe vacuum sources disclosed herein. In such examples, the removing mayinclude activating the vacuum source. Removing the fluid from the fluidcollection device via the conduit may include removing the fluid into afluid storage container.

The method 2600 may include collecting the fluid(s) that are removedfrom the fluid collection device, such as in the fluid storagecontainer. The method may include one or more of testing or quantifyingthe amount of fluid removed.

The fluid collection devices, systems, and methods disclosed hereinprovide for immediate control of fluids emitted from a wearer via theprotruding portion of the fluid permeable body as well as securepositioning of protruding portion between the labia of a wearer, whichprevents leakage and soiling of the wearer's clothing, bedding, and caretakers.

As used herein, the term “about” or “substantially” refers to anallowable variance of the term modified by “about” by ±10% or ±5%.Further, the terms “less than,” “or less,” “greater than”, “more than,”or “or more” include as an endpoint, the value that is modified by theterms “less than,” “or less,” “greater than,” “more than,” or “or more.”

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments are contemplated. The various aspects andembodiment disclosed herein are for purposes of illustration and are notintended to be limiting.

What is claimed is:
 1. A fluid collection device, comprising: a fluidimpermeable barrier at least partially defining a chamber and anopening, the fluid impermeable barrier including a first end region anda second end region; a fluid permeable body positioned at leastpartially within the chamber to extend across at least a portion of theopening and configured to allow fluid to move away from the opening, thefluid permeable body including a protruding portion protruding out ofthe opening and that is sized and shaped to fit between labia of awearer; and a conduit disposed within the chamber for removing fluidstherefrom.
 2. The fluid collection device of claim 1 wherein the fluidpermeable body includes a fluid permeable support and a fluid permeablemembrane disposed over at least a portion of the fluid permeablesupport.
 3. The fluid collection device of claim 1, further comprising ameans for retaining the protruding portion between the labia of thewearer.
 4. The fluid collection device of claim 3 wherein at least aportion of one or more of the fluid impermeable barrier and the fluidpermeable body are shaped to accommodate the labia therein and the meansfor retaining the protruding portion between the labia of the wearerincludes the at least a portion of one or more of the fluid impermeablebarrier and the fluid permeable body.
 5. The fluid collection device ofclaim 3 wherein: the means for retaining the protruding portion betweenthe labia of the wearer includes adhesive flaps disposed on the fluidimpermeable barrier; and the adhesive flaps include an adhesive on awearer-facing side thereof.
 6. The fluid collection device of claim 5wherein the adhesive flaps are sized and positioned on the fluidimpermeable barrier to secure to the legs, pelvis, or buttocks of thewearer.
 7. The fluid collection device of claim 3 wherein the means forretaining the protruding portion between the labia of the wearerincludes one or more straps sized and configured to wrap around one ormore anatomical features of the wearer.
 8. The fluid collection deviceof claim 7 wherein the one or more straps include a waist band disposedon the second end region of the fluid impermeable barrier.
 9. The fluidcollection device of claim 8 wherein the one or more straps include astrap extending from the fluid collection device to a back of the waistband to form an undergarment.
 10. The fluid collection device of claim 3wherein: the means for retaining the protruding portion between thelabia of the wearer includes an additional protrusion extending from thefirst end region of the fluid impermeable barrier on a wearer-facingside thereof; and the additional protrusion is sized and shaped to fitbetween buttocks of the wearer.
 11. The fluid collection device of claim3 wherein the fluid impermeable barrier is shaped as a trough and theopening is disposed at a wearer-facing side of the trough, the fluidcollection device includes a plurality of spring members extendinglongitudinally along the opening, the plurality of spring members beingconfigured to provide an outward bias on the opening, and the fluidpermeable body protrudes from the opening.
 12. The fluid collectiondevice of claim 3 wherein the fluid impermeable barrier includes extendsover a portion of the protruding portion.
 13. The fluid collectiondevice of claim 12 wherein the fluid impermeable barrier has asubstantially flat arcuate shape on a wearer-facing side thereof and anarrow portion sized and shaped to provide a grip section for grippingor pinching in a hand.
 14. The fluid collection device of any of claims12-13, further comprising one or more adhesive flaps disposed on thefluid impermeable barrier for attaching to the wearer.
 15. The fluidcollection device of any of claims 12-14, further comprising a foldablebody configured to attach to the fluid impermeable barrier and thewearer and bias the protruding portion toward the wearer.
 16. The fluidcollection device of claim 15 wherein the foldable body includes: afirst fold along a center thereof; and a cutout portion defined betweencuts perpendicular to the first fold; and a second fold in the in thecutout portion, the second fold being oriented to fold in a directionopposite to the first fold.
 17. The fluid collection device of claim 16wherein at least a portion of the fluid impermeable barrier is disposedbetween the first fold and the second fold.
 18. The fluid collectiondevice of claim 16 wherein: the fluid impermeable barrier includes aflange longitudinally extending along a back side thereof; and thesecond fold of the foldable body is disposed beneath the flange.
 19. Thefluid collection device of claim 3 wherein: the fluid impermeablebarrier includes a substantially domed shape on a wearer-facing sidethereof and the opening is defined at a base edge of the domed shape;the fluid permeable body is attached to the chamber of the fluidimpermeable barrier at the first end region and the second end region;and the fluid permeable body is substantially cylindrical and curved tobend outwardly from the opening.
 20. The fluid collection device ofclaim 19 wherein the fluid impermeable barrier includes one or moretransparent portions.
 21. The fluid collection device of any of claims19-20 wherein the fluid impermeable barrier includes a narrow portionsized and shaped to provide a grip section for gripping or pinching in ahand.
 22. A fluid collection system, the system comprising: a fluidcollection device according to any of claims 1-21; a fluid storagecontainer fluidly connected to the fluid collection device via theconduit, the fluid storage container being configured to store fluidstherein; and a vacuum source fluidly connected to the fluid storagecontainer, the vacuum source being configured to provide vacuum forceinto the chamber via the fluid storage container and the conduit. 23.The fluid collection system of claim 22 wherein the fluid storagecontainer includes a canister.
 24. The fluid collection system of claim22 wherein the vacuum source includes one or more of a vacuum pump, awall-mounted vacuum line, or a hand pump.
 25. A method to collect fluid,the method comprising: positioning any of the fluid collection devicesof claims 1-20 adjacent to a urethra of a wearer effective to positionthe protruding portion between the labia of the wearer; receiving fluidfrom the urethra into the fluid collection device; and removing thefluid from the fluid collection device via the conduit.
 26. The methodof claim 26, further comprising engaging the means for retaining theprotruding portion between the labia of the wearer.
 27. The method ofclaim 26 wherein: the means for retaining the protruding portion betweenthe labia of the wearer includes adhesive flaps disposed on the fluidimpermeable barrier; and engaging the means for retaining the protrudingportion between the labia of the wearer includes adhering the adhesiveflaps to the wearer or clothing of the wearer.
 28. The method of claim26 wherein: the means for retaining the protruding portion between thelabia of the wearer includes one or more straps sized and configured towrap around one or more anatomical features of the wearer; and engagingthe means for retaining the protruding portion between the labia of thewearer includes wrapping the one or more straps around at least one ofthe legs, pelvis, or buttocks of the wearer.
 29. The method of claim 26wherein: the means for retaining the protruding portion between thelabia of the wearer includes an additional protrusion extending from thefirst end region of the fluid impermeable barrier on a wearer-facingside thereof; and engaging the means for retaining the protrudingportion between the labia of the wearer includes positioning theadditional protrusion between the buttocks of the wearer.
 30. The methodof claim 26 wherein: the fluid impermeable barrier shaped as a troughand the opening is disposed at a wearer-facing side of the trough; themeans for retaining the protruding portion between the labia of thewearer includes a plurality of spring members extending longitudinallyalong the opening, the plurality of spring members being configured toprovide an outward bias on the opening; and engaging the means forretaining the protruding portion between the labia of the wearerincludes: pinching the fluid impermeable barrier to bias the pluralityof spring members inward, placing the protruding portion between thelabia of the wearer, and releasing the plurality of spring members. 31.The method of claim 26 wherein: the means for retaining the protrudingportion between the labia of the wearer includes a foldable bodyconfigured to attach to the fluid impermeable barrier and the wearer andto bias the protruding portion toward the wearer; and engaging the meansfor retaining the protruding portion between the labia of the wearerincludes attaching lateral ends of the foldable body to the inner thighsof the wearer.
 32. The method of claim 26 wherein: the fluid impermeablebarrier includes a substantially domed shape and sized to at leastpartially fit over the labia of the wearer and the opening is defined ata base edge of the domed shape; the fluid permeable body is attached tothe chamber of the fluid impermeable barrier at the first end region andthe second end region; the fluid permeable body is substantiallycylindrical and curved to bend outwardly from the opening; andpositioning any of the fluid collection devices of claims 1-20 adjacentto a urethra of a wearer effective to position the protruding portionbetween the labia of the wearer includes positioning the curved fluidpermeable body between the labia of the wearer.
 33. The method of claim32 wherein: the means for retaining the protruding portion between thelabia of the wearer includes the opening; and engaging the means forretaining the protruding portion between the labia of the wearerincludes positioning the opening around at least a portion the labia ofthe wearer.